Anacura

Analytical solutions

  • Product characterization
  • Method development
  • Validation and transfer
  • Release
  • Stability testing (ICH,in-use stability, cyclic stress)
  • Shelf life prediction (ASAP)
  • Forced degradation
  • Excipient compatibility

 

Experience

  • Drug substance
  • Drug product: solids, liquids, injectables
  • Complex formulations
    • Low solubility products
    • Microspheres
    • Liposomal products
    • Extended release formulations
    • Combination products in range of strengths
    • API loaded medical devices

Testing capabilities

Chromatography / Electrophoresis

  • HPLC & UPLC (UV/DAD/CAD/MS/ELSD/FLD)
  • Gas chromatography (GC)
    • liquid & headspace
    • FID & TCD
  • Capillary electrophoresis (CE)

Physico-chemical testing

  • Differential Scanning Calorimetry (DSC)
  • Laser Diffraction
  • Light obscuration
  • Hardness
  • Disintegration
  • Friability
  • XRD

Mass spectrometry

  • LC-MS
  • GC-MS

Karl Fischer

  • Volumetric
  • Coulometric (with/without VAP)

Spectroscopy

  • FT-IR
  • UV-VIS

Dissolution

  • USP type 1 (baskets)
  • USP type 2 (paddles)
  • QC (real-time & accelerated)
  • Biorelevant

Wet chemistry

  • Osmolality
  • pH
  • Density
  • Viscosity
  • Heavy metals
  • Sulfated ash
  • Titration

Other

  • Water activity
  • Appearance 

Color, particulate matter, visible particles

  • Solubility
  • Microbiology (outsourced)
  • Endotoxines

Meet our scientist